PMA P000009S121
- Device
- Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S121
- Product code
- MRM
- Decision date
- 2025-09-15
- Classification
- Cardiovascular
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- updates to the communication tool used in the manufacturing of IPGs and ICDs
Current openFDA PMA Record#
- Device
- Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S121
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2025-09-15
- Decision code
- OK30
- Date received
- 2025-08-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updates to the communication tool used in the manufacturing of IPGs and ICDs